The present invention relates generally to containers such as flexible bags, IV containers or the like for delivering medicinal fluids to patients, and more specifically to such containers having multiple ports, one such port, called an administration port used for delivering the primary fluid stored in the container, and a separate port, called a medication port used for introducing a desired additive, such as a medicine or medicinal ingredient, into the solution in the container. In certain situations, the medication port is also used to withdraw fluid (air or liquid) from the container.
Medical clinicians desire two distinct ports (medication and administration ports) for providing the range of infusion therapies common in current medical practice. Both ports are preferably rigid to allow safe, ergonomic handling and prevent injury or container damage when using needles or spikes on IV sets or other devices (including reconstitution devices called “recon”). Certain recon devices attach to the medication port, and others attach to the administration port. A growing use of automated admixture systems calls for rigid ports with adequate spacing for machine interface.
The medication (“med”) and administration (“admin”) ports are preferably independently accessible. In certain situations, the med port should be accessed while the admin port is “spiked” by an administration set. The following two scenarios provide examples of this situation:
Medication is added to the bag while it is already spiked, hanging, and infusing to the patient.
For cytotoxic/oncolytic medications, NIOSH guidelines require the pharmacy to spike the bag and prime the administration set before adding the medication to the bag. This procedure reduces risk of nurse exposure to the cytotoxic agent when connecting the primed IV set to the patient catheter or IV line.
It is preferred that clinicians are able to access each port individually, maintain aseptic technique, and avoid damaging or touch contamination of the other port. For example, the sterile cover on the admin port should not be disturbed or damaged when accessing the med port with an antiseptic wipe, spray, needle, or recon device. In another example, the clinician should be able to spike the admin port if a recon device is already attached to the med port.
It is desirable for each med and admin port to have a sufficiently large diameter, preferably in the range of 10 mm, that is considered adequate for providing target area to safely receive needles or IV spikes. If either the needle or the spike “misses” the target, container damage or clinician injury can occur. In addition, if the needle or spike is inserted through the target but at a certain angle, it may unintentionally strike the internal wall of the port lumen. Needles or spikes striking the port internal wall can generate PM, delay workflow/therapy, or produce a no-flow or disconnect condition. Also, clinicians take special care to avoid the needles and spikes coming in contact with each other during the medical administration process.
Many port designs include flanges or protrusions beyond the primary cylindrical protrusion to accommodate sterile covers, device attachment, provide finger protection during needle or spike use, prevent touch contamination during use, and provide improved ergonomic grip. These flanges or protrusions add to the need for port spacing.
It is desirable to reduce dead space between each port lumen and the container bulk contents to similarly reduce residual volume after gravity infusion and to also reduce the risk of pooling concentrated residual medication in or near the med port.
The container design should provide “access evidence” for both ports. If clinicians encounter an IV container that is missing a “cover” on either port for unknown reasons, they will typically discard the container because they cannot be certain that something has or has not been added to the container. Typical IV containers include a removable sterile cover on the admin port that provides “access evidence” as long as it cannot be easily re-attached and enables aseptic connection when connecting the spike on an IV infusion set or other device.
However, the majority of typical IV containers do not include a sterile cover on the med port. Therefore, clinicians should disinfect or “swab” the med port before access. However, these containers generally include an overpouch (“OP”) that provides several functions, including barrier properties for shelf life. The OP provides the “access evidence” function for an un-covered med port. For IV containers that do not have an OP, including an access evident cover on the med port is highly desirable. The med port cover should also provide a sterile barrier so the clinician does not need to disinfect or swab the med port prior to the first access.
On subsequent med port accesses, the med port should be swabbed, which introduces a sterile cover requirement unique to the med port but not required for an admin port: med port design shall enable swabbing after sterile cover removal. Swabbing the admin port after sterile cover removal is not required because the admin port is accessed only once.
To prevent adding additional medication to an IV container after the pharmacist has admixed a patient-specific “dose”, pharmacists often add a “post-admix cover” or “additive cap” to the med port after admixing, which indicates to other clinicians that med has been added and nothing else should be added to the container. Several “post-admix cover” designs are available, including foils and rigid molded components. Ideally, the “post-admix cover” is highly visible, not easily removable and is rigid to prevent needle access. Thus, any med port should accommodate attachment of a range of “post-admix covers” to accommodate current clinical practice. The “post-admix cover” does not need to provide a sterile barrier. The “post-admix cover” products represent a distinct component and inventory item purchased by the hospital pharmacy.
Ports are preferably manufacturable in high volumes at low cost, referred to as “design for manufacturability” or “DFM”. Automated machine tooling and fixtures are typically used to handle, convey, and position the ports and insert/seal port components including internal septums, plugs, stoppers, or sleeves and external covers including heat sealed films, snap fit molded components, and welded components. DFM requirements add to the need for port spacing.
Based on the design criteria summarized above, the ports on conventional IV containers are typically spaced 1-2″ (25-50 mm) apart. Current methods for making ISBM containers with a single open end limit the opening size to approximately an 18 mm i.d. circle with a 29 mm diameter flange. For the single-ended ISBM containers made using current methods, the 18 mm i.d. circular opening with 29 mm o.d. flange does not allow placement of two parallel ports with ˜10 mm diameter with spacing adequate to avoid the needle or spike striking the inside wall of the 18 mm id opening. This dimensional limitation has provided a design challenge for port manufacturers.